BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4120841 · Received September 26, 2014

    Report

    Report Number
    1531186-2014-04478
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USER'S NEPHEW THAT THE CLAMP WHICH SECURES THE COMMODE TO THE TOILET IS NOT SCREWING CLOSED. PER THE USER'S MANUAL-WARNING: ALWAYS MAKE SURE THAT THE RAISED TOILET SEAT IS SECURELY IN PLACE AND STABLE BEFORE EACH USE. ALTHOUGH THE RAISED TOILET SEAT IS DESIGNED FOR USE ON MOST POPULAR TOILETS, IT MAY NOT WORK ON CERTAIN UNUSUAL OR ARTISTIC BOWLS. NO PATIENT INJURY REPORTED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601492 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN 1301RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other